Recall Z-1409-2022 ยท FSO Microscope, Surgical, General & Plastic Surgery
Aesculap Implant Systems LLC
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
| Date | Feb 19, 2021 |
| Status | Completed |
| Reason | Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system. |
| Root cause | Material/Component Contamination |
| Action | An Urgent Market Withdrawal Notification letter issued February 19, 2021 was mailed USPS certified. The letter identifies the Universal Robot UR5 arm as part of hte Aesculap Aeos System and requests the customer return the acknowledgement form and schedule repair by service technician. |
| Quantity | 1 |
| Distribution | United States: NE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.